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ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Barlow R, Price P, Reid TD, Hunt S, Clark GW, Havard TJ, Puntis MC, Lewis WG. Prospective multicentre randomised controlled trial of early enteral nutrition for patients undergoing major upper gastrointestinal surgical resection. Clin Nutr. 2011 Oct; 30(5): 560-566.

PubMed ID: 21601319
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To determine if early enteral nutrition (EEN) was well-tolerated, safe and improved clinical outcomes of post-operative morbidity, mortality and length of hospital stay. 

Inclusion Criteria:

Adults admitted with a suspected upper gastrointestinal malignancy and referred for major elective surgery.

Exclusion Criteria:
  • Less than 18 years old
  • Unwilling or unable to give informed consent
  • Pregnant, pre-operative infection or previous intestinal surgery resulting in residual small intestine length of less than 100cm.
Description of Study Protocol:

Recruitment

South East Wales Upper Gastrointestinal Cancer Network over 30 months ending in July 2006.

Design

Open, prospective, pragmatic RCT.

Blinding Used

Unblinded study but data entry and statistical analysis were blinded to group allocation.

Intervention

Feeding jejunostomy  at time of surgery.

Statistical Analysis

Non-parametric tests of difference for independent groups (Mann Whitney U-test) and categorical data were analyzed using the Chi2 test. Data were analyzed on an Intention-to-Treat (ITT) and Per Protocol (PP) basis. 

Data Collection Summary:

Timing of Measurements

 Length of hospital stay (LOHS), six and 12 weeks post-discharge.

Dependent Variables

  • LOHS: Time from the date of the index operation to the date the operating surgeon assessed the patient was medically fit for discharge service home or a sub-acute service or death, whichever came first. Precise discharge data were used:
    • Ability to mobilize out of bed and ambulate
    • Ability to prepare a drink or food and get to the lavatory in their home
  • Secondary endpoints:
    • Operative morbidity and mortality
    • Re-admission rates.

Independent Variables

Jejunostomy feeding begun within 12 hours of surgery at 20ml per hour of a standard 1kcal per ml commercial whole protein enteral feed with the aim to achieve to minimum of half of nutritional requirements by the fifth post-op day.

Control Variables

Nothing by mouth, with hydration by IV fluids until the introduction of oral fluids and diet.

 

Description of Actual Data Sample:
  • Initial N: 121 (83 males, 38 females))
  • Attrition (final N): 121
  • Age: 64 (57 to 72)
  • Anthropometrics: Comparable other than the discrepancy regarding American Society Anesthesiology grade
  • Location: Cardiff, UK.
Summary of Results:

Findings

  • Median LHOS for EEN was 16 days vs. 19 d for control (CON), P=0.023 for the intention-to-treat analysis. Per Protocol analysis gave the same number of days for each group with P=0.011.
  • There were no statistical significant differences between the two groups for hospital re-admissions after EEN with six weeks of discharge or between six and 12 weeks after discharge
  • Operative morbidity (wound infections, chest infections and anastomotic leaks) was less common after EEN (N=21) vs. CON (N=29); 32.8% vs. 50.9%, P<0.044. The three post-operative deaths occurred within 30 days of surgery were in the EEN group but none were attributed to the EEN. 
  • Fewer patients were discharged on continuing therapy but this difference was not statistically significant
  • The median duration of EEN was 12.4 (range six to 40 days) days. The median percentage daily nutritional requirement achieved in the first post-op week in EEN was 69% compared with 0% in CON. The median calorie intake during the first post-operative week was 7,626kcal in EEN vs. 0kcal in CON. The median protein intake during the first post-operative week was 328g in EEN vs. 0g in CON. 
Author Conclusion:

EEN was associated with significantly shortened length of hospital stay and improved clinical outcomes.

Funding Source:
Not-for-profit
The Health Foundation, London, UK
Other non-profit:
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes